PMID- 32038757
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 1941-2789 (Print)
IS  - 1941-2789 (Linking)
VI  - 12
IP  - 11
DP  - 2019 Nov
TI  - Safety and Tolerability of Sarecycline for the Treatment of Acne Vulgaris: 
      Results from a Phase III, Multicenter, Open-Label Study and a Phase I 
      Phototoxicity Study.
PG  - E53-E62
AB  - Objective: We sought to evaluate the safety, tolerability, and patterns of use 
      for the once-daily oral, narrow-spectrum antibiotic sarecycline in patients with 
      moderate-to-severe acne vulgaris during a 40-week Phase III, multicenter, 
      open-label extension study. Participants: Patients aged nine years or older with 
      moderate-to-severe acne who completed one of two prior Phase III, double-blind, 
      placebo-controlled, 12-week trials in which they received sarecycline 
      1.5mg/kg/day or placebo were included. Measurements: The primary assessment was 
      the safety of sarecycline 1.5mg/kg/day for 40 weeks as indicated by adverse 
      events (AEs), vital signs, electrocardiograms, clinical laboratory tests, and 
      physical examinations. Patterns of sarecycline use were a secondary assessment. 
      Results: The safety population included 483 patients; 354 patients (73.3%) 
      completed the study. The most common reasons for premature discontinuation were 
      withdrawal by the patient (14.5%), lost to follow-up (7.9%), and AEs (2.5%). The 
      most common treatment-emergent AEs (TEAEs) were nasopharyngitis (3.7%), 
      upper-respiratory-tract infection (3.3%), headache (2.9%), and nausea (2.1%). 
      Clinical laboratory evaluations suggested no clinically meaningful differences 
      between the treatment sequences. Rates of TEAEs commonly associated with other 
      tetracycline antibiotics include dizziness (0.4%) and sunburn (0.2%), and for 
      gastrointestinal TEAEs, nausea (2.1%), vomiting (1.9%), and diarrhea (1.0%). Also 
      reported herein are the results of a Phase I phototoxicity study. Conclusion: 
      Patients aged nine years or older with moderate-to-severe acne vulgaris who 
      received sarecycline once daily for up to 40 weeks showed low rates of TEAEs, 
      with nasopharyngitis, upper-respiratory-tract infection, headache, and nausea 
      being the only TEAEs reported by 2% or more of patients. No clinically meaningful 
      safety findings were noted. ClinicalTrials.gov Registration: NCT02413346.
CI  - Copyright (c) 2019. Matrix Medical Communications. All rights reserved.
FAU - Pariser, David M
AU  - Pariser DM
AD  - Dr. Pariser is with the Eastern Virginia Medical School and Virginia Clinical 
      Research, Inc. in Norfolk, Virginia.
AD  - Dr. Green is with the George Washington University School of Medicine in 
      Washington, DC.
AD  - Dr. Lain is with the Austin Institute for Clinical Research in Pflugerville, 
      Texas.
AD  - Drs. Schmitz, Chinigo, and Berk are with Allergan plc in Irvine, California.
AD  - Dr. McNamee is with Allergan Biologics Ltd. in Liverpool, United Kingdom.
FAU - Green, Lawrence J
AU  - Green LJ
AD  - Dr. Pariser is with the Eastern Virginia Medical School and Virginia Clinical 
      Research, Inc. in Norfolk, Virginia.
AD  - Dr. Green is with the George Washington University School of Medicine in 
      Washington, DC.
AD  - Dr. Lain is with the Austin Institute for Clinical Research in Pflugerville, 
      Texas.
AD  - Drs. Schmitz, Chinigo, and Berk are with Allergan plc in Irvine, California.
AD  - Dr. McNamee is with Allergan Biologics Ltd. in Liverpool, United Kingdom.
FAU - Lain, Edward L
AU  - Lain EL
AD  - Dr. Pariser is with the Eastern Virginia Medical School and Virginia Clinical 
      Research, Inc. in Norfolk, Virginia.
AD  - Dr. Green is with the George Washington University School of Medicine in 
      Washington, DC.
AD  - Dr. Lain is with the Austin Institute for Clinical Research in Pflugerville, 
      Texas.
AD  - Drs. Schmitz, Chinigo, and Berk are with Allergan plc in Irvine, California.
AD  - Dr. McNamee is with Allergan Biologics Ltd. in Liverpool, United Kingdom.
FAU - Schmitz, Carsten
AU  - Schmitz C
AD  - Dr. Pariser is with the Eastern Virginia Medical School and Virginia Clinical 
      Research, Inc. in Norfolk, Virginia.
AD  - Dr. Green is with the George Washington University School of Medicine in 
      Washington, DC.
AD  - Dr. Lain is with the Austin Institute for Clinical Research in Pflugerville, 
      Texas.
AD  - Drs. Schmitz, Chinigo, and Berk are with Allergan plc in Irvine, California.
AD  - Dr. McNamee is with Allergan Biologics Ltd. in Liverpool, United Kingdom.
FAU - Chinigo, Amy S
AU  - Chinigo AS
AD  - Dr. Pariser is with the Eastern Virginia Medical School and Virginia Clinical 
      Research, Inc. in Norfolk, Virginia.
AD  - Dr. Green is with the George Washington University School of Medicine in 
      Washington, DC.
AD  - Dr. Lain is with the Austin Institute for Clinical Research in Pflugerville, 
      Texas.
AD  - Drs. Schmitz, Chinigo, and Berk are with Allergan plc in Irvine, California.
AD  - Dr. McNamee is with Allergan Biologics Ltd. in Liverpool, United Kingdom.
FAU - McNamee, Brian
AU  - McNamee B
AD  - Dr. Pariser is with the Eastern Virginia Medical School and Virginia Clinical 
      Research, Inc. in Norfolk, Virginia.
AD  - Dr. Green is with the George Washington University School of Medicine in 
      Washington, DC.
AD  - Dr. Lain is with the Austin Institute for Clinical Research in Pflugerville, 
      Texas.
AD  - Drs. Schmitz, Chinigo, and Berk are with Allergan plc in Irvine, California.
AD  - Dr. McNamee is with Allergan Biologics Ltd. in Liverpool, United Kingdom.
FAU - Berk, David R
AU  - Berk DR
AD  - Dr. Pariser is with the Eastern Virginia Medical School and Virginia Clinical 
      Research, Inc. in Norfolk, Virginia.
AD  - Dr. Green is with the George Washington University School of Medicine in 
      Washington, DC.
AD  - Dr. Lain is with the Austin Institute for Clinical Research in Pflugerville, 
      Texas.
AD  - Drs. Schmitz, Chinigo, and Berk are with Allergan plc in Irvine, California.
AD  - Dr. McNamee is with Allergan Biologics Ltd. in Liverpool, United Kingdom.
LA  - eng
SI  - ClinicalTrials.gov/NCT02413346
PT  - Journal Article
DEP - 20191101
PL  - United States
TA  - J Clin Aesthet Dermatol
JT  - The Journal of clinical and aesthetic dermatology
JID - 101518173
PMC - PMC6937166
OTO - NOTNLM
OT  - Acne vulgaris
OT  - drug-related adverse reactions
OT  - drug-related side effects
OT  - sarecycline
OT  - tetracycline
COIS- FUNDING:This study was sponsored by Allergan plc, Dublin, Ireland. Writing and 
      editorial assistance was provided to the authors by Regina Kelly, MA, of Peloton 
      Advantage, LLC, an OPEN Health company, in Parsippany, New Jersey, and was funded 
      by Allergan plc and Almirall, LLC. DISCLOSURES:Dr. Pariser has been a consultant 
      for Atacama Therapeutics, Bickel Biotechnology, Biofrontera AG, Celgene 
      Corporation, Dermira, LeoPharma, Novartis, Regeneron, Sanofi, TDM SurgiTech, 
      Inc., TheraVida, and Valeant Pharmaceutical International; a principal 
      investigator for LeoPharma, Abbott Laboratories, Almirall, Amgen, AOBiome, LLC, 
      Asana Biosciences, LLC, Bickel Biotechnology, Celgene Corporation, Dermavant 
      Sciences, Dermira, Eli Lilly and Company, Menlo Therapeutics, Merck & Co., Inc., 
      Novo Nordisk A/S, Ortho Dermatologics, Pfizer Inc., Regeneron, Stiefel, and 
      Valeant Pharmaceuticals International; on a data safety monitoring board for BMS; 
      and on an advisory board for Pfizer. Dr. Green has been an investigator, 
      consultant, and speaker for Almirall, Kamedis, Ortho Derm and an investigator for 
      Sol-Gel. Dr. McNamee is employed by Allergan plc and owns stock in Allergan plc. 
      Dr. Berk was an employee of Allergan plc at the time the study was conducted and 
      owns stock in Allergan plc. The other authors have no conflicts of interest 
      relevant to the content of this article.
EDAT- 2020/02/11 06:00
MHDA- 2020/02/11 06:01
PMCR- 2019/11/01
CRDT- 2020/02/11 06:00
PHST- 2020/02/11 06:00 [entrez]
PHST- 2020/02/11 06:00 [pubmed]
PHST- 2020/02/11 06:01 [medline]
PHST- 2019/11/01 00:00 [pmc-release]
PST - ppublish
SO  - J Clin Aesthet Dermatol. 2019 Nov;12(11):E53-E62. Epub 2019 Nov 1.